Strong Hearts for New York: A multilevel community-based randomized cardiovascular disease risk reduction intervention for rural women.

Background: Rural midlife and older women have high rates of cardiovascular disease (CVD) risk factors and lower access to healthy living resources. The Strong Hearts, Healthy Communities (SHHC) intervention, tailored to the needs of rural women, demonstrated effectiveness on many outcomes. The purpose of the Strong Hearts for New York (SHNY) study is to evaluate the efficacy of an enhanced version of the curriculum (SHHC-2.0).

Methods: SHNY is a randomized controlled efficacy intervention, comparing participants receiving the SHHC-2.0 curriculum with a delayed intervention control group. SHHC, informed by formative research, includes core elements from three evidence-based programs. Changes based on extensive outcome and process evaluation data were made to create SHHC-2.0. Classes will meet twice weekly for 24 weeks and include individual, social, and environmental components. Overweight women age 40 and over will be recruited from 11 rural, medically underserved communities in New York; data will be collected at baseline and 12, 24, 36, and 48 weeks across individual, social, and environmental levels. Primary outcome is body weight. Secondary outcomes include Simple 7 (composite CVD risk score), anthropometric, physiologic, biochemical, physical activity, and dietary intake measures; healthy eating and exercise self-efficacy and attitudes; and self-efficacy of the social network of participants.

Discussion: The aims of this study are to evaluate the efficacy of the enhanced SHHC-2.0 program for participants, changes among participants' social networks, and the difference in outcomes when participants are and are not provided with technological tools (Fitbit and body composition scale).